Title: Project Leader - Analytical
Location: Co. Mayo
Seeking an experienced Project Leader for the Biologics Division with an international pharmaceutical company in Co. Mayo, Ireland.
- Reporting to the Head of Analytical Strategy & Scientific Support.
- Research and develop new analytical methodologies which meet client requirements and company strategic objectives.
- Certify all new methods are validated in accordance with ICH guidelines.
- Compose study plans and carry out learning in strict accordance with study plan and SOPs, ensuring they fall in with GMP regulatory compliance.
- Link with the Quality Department for the generation of audit responses, deviation reports and the collection of study reports.
- Responsible for managing laboratory investigations when necessary.
- In charge of reporting project progress to Management.
- Giving technical training to scientific team.
- Liaise with clients daily with regards to current and upcoming projects.
- Involvement with client and regulatory audits.
- Ensuring all new equipment is qualified and validated in accordance with both GMP and corporate validation requirement standards and guidelines.
- Create new and update current SOPs.
- Generate risk assessments for various projects.
Minimum requirements for Project Leader - Analytical, Co. Mayo:
- PhD in relevant science discipline (e.g., Chemistry, Biotechnology, Biochemistry)
- Minimum of 3 years relevant experience in Scientific Research, ideally within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Exposure to study design, assay development, optimization, ICH analytical validation and project management.
- Experience in analytical techniques is essential (e.g., HPLC, UPLC, GC, flame photometry).
- Expertise to project manage multiple studies.
- Experience and knowledge with statistical software.
- Ability for problem solving and to work on own initiative.
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